Events

Retiro De Equipo (Recall) de Device Recall Emergency Powered Ventilator Resusicitator

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare, LLC.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    67004
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1072-2014
  • Fecha de inicio del evento
    2013-10-01
  • Fecha de publicación del evento
    2014-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125259
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Warmer, infant radiant - Product Code BTL
  • Causa
    Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.
  • Acción
    GE Healthcare sent an Urgent Medical Device Correction letter dated November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.

Device

Device Recall Emergency Powered Ventilator Resusicitator
  • Modelo / Serial
  • Clasificación del producto
    Anesthesiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA Nationwide including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL,GA. HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY; and the countries of Albania, Austria, Australia, Bahrain, Belarus, Belgium, Canada, China, Costa Rica, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Greece, Guatemala, Germany, Honduras, Hong Kong, Hungry, India, Indonesia, Ireland, Italy, Kazakhstan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Saudi Arabia, South Africia, Spain, Sweden, Switzerland Turkey, United Arab, United Kingdom, and Venezuela.
  • Descripción del producto
    GE Healthcare - Giraffe¿ and Panda¿ iRes Infant Warmer || Product Usage: || The infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonates transition to the external environment or to provide a controlled open environment. An optional integrated Sp02 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin and pulse rate.
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Dirección del fabricante
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
    General Electric Company
  • Source
    USFDA